MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT

Model Number	314.10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.A product investigation was conducted: investigation flow: damage visual inspection: the cannulated 2.5mm hexagonal screwdriver shaft (product code: 314.10, lot number: 3766580) was received at us cq for investigation.Visual inspection of the received device indicated that the distal hex tip was slightly twisted and bent.No breakage was observed on the device.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection cannot be performed due to the post-manufacturing damage.Document/specification review: the drawing(s) reflecting the current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.The broken complaint condition was not confirmed.Conclusion: the complaint was not confirmed for the received device as no breakage was observed on the device.The distal hex tip of the device was slightly twisted and bent.While no definitive root cause could be determined based on the provided information, it is possible that the device was encountered unintended forces.  there was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A device history record (dhr) review was conducted: part: 314.100.Lot: 3766580.Manufacturing site: (b)(4).Release to warehouse date: may 10, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of the loaner set at fsl ups lyndhurst, nj site, it was observed that the cannulated hexagonal screwdriver shaft was broken.There was no patient involvement.This complaint involves 1 device.This report is for (1) cannulated 2.5mm hexagonal screwdriver shaft.This is report 1 of 1 (b)(4).

• Brand Name: CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10434932
• Report Number: 2939274-2020-03714
• Device Sequence Number: 3668974
• Product Code: HXX
• UDI-Device Identifier: 10886982188502
• UDI-Public: 10886982188502
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 314.10
• Device Catalogue Number: 314.10
• Device Lot Number: 3766580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1